Novocure has received approval from the US Food and Drug Administration (FDA) for its new Head Flexible Electrode (HFE) transducer arrays.
These arrays are designed for use with Optune Gio in treating adult glioblastoma multiforme (GBM) patients.
Optune Gio is a portable, wearable device approved by the FDA to treat GBM in adults aged 22 or older.
It delivers Tumor Treating Fields (TTFields) to treat cancer. TTFields use alternating electric fields applied through non-invasive, wearable arrays.
These fields disrupt the rapid division of cancer cells by exerting physical forces on their electrically charged components during cell division.
The new HFE arrays feature a flexible polymer material, replacing the ceramic discs in current Optune Gio arrays. This makes the new arrays one-third lighter and 50% thinner, Switzerland-based Novocure said.
Novocure chief operating officer Mukund Paravasthu said: “At Novocure we recognise product innovation must deliver meaningful results for our patients.
“The newly FDA approved HFE arrays are lighter, thinner and designed to be more comfortable, clear benefits for the patient.
“We look forward to introducing the new arrays in the US and will continue our work to deliver product innovations that prioritise the needs of people using our treatments.”
For individuals with newly diagnosed GBM, Optune Gio is used with temozolomide (TMZ) chemotherapy. For recurrent tumours, Optune Gio can be used alone as an alternative to standard medical therapy.
Novocure plans to transition Optune Gio users in the US to the new HFE arrays by mid-2025 through a controlled transition plan.
The oncology company is focused on extending survival in aggressive cancers through its TTFields therapy.
Its products are approved in certain countries for treating adult patients with glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma, and pleural mesothelioma.
Novocure is also conducting clinical trials to explore the use of TTFields in treating glioblastoma, non-small cell lung cancer, and pancreatic cancer.
Last month, the Swiss firm received FDA approval for Optune Luna, which has been approved for use alongside PD-1/PD-L1 inhibitors or docetaxel to treat adult patients with metastatic non-small cell lung cancer.
